Section 75206 - Disinfection and Storage(a) If a disinfectant chemical other than formaldehyde is used, a process validation to assess and assure the safety and effectiveness as a disinfectant shall be performed and the results submitted to the Department for approval prior to use as a disinfectant for the reprocessing of dialyzers; otherwise the remainder of the subsections contained in this section shall apply. Within 30 days of receipt of the request for approval of a disinfectant chemical other than formaldehyde,the Department shall inform the applicant, in writing, that the request is complete and accepted for consideration or that the request is deficient and what specific information is required. The Department shall approve or disapprove the request within 90 days of receipt.(b) Alternative disinfectant chemical(s) may be used and the remainder of this section shall not apply provided that the following requirements are met: (1) The disinfectant chemical(s) shall have marketing approval for use as a dialyzer disinfectant from the federal Food and Drug Administration.(2) Labeling of the disinfectant chemical(s) shall include procedures and adequate directions for use for the disinfection and storage of dialyzers and disinfection chemical(s).(3) The dialysis facility shall follow the procedures of the manufacturer for the disinfection and storage of dialyzers.(c) The disinfectant chemical shall be Formaldehyde Solution, USP (nominal 37 percent formaldehyde).(d) Water shall be added to the Formaldehyde Solution to make the disinfectant solution chemical concentration a minimum of 1.5 percent formaldehyde. A test capable of detecting this percentage formaldehyde shall be performed to initially validate the procedures for making the formaldehyde chemical solution at the desired percentage. For automated reuse machines which proportion formaldehyde, the validation test shall be similarly applied.(e) The storage of the formaldehyde solution shall be at room temperature in a designated and marked container (name and solution concentration, date of solution makeup) and equipped with a sealable closure.(f) The formaldehyde solution-filled dialyzer shall be stored at room temperature for a minimum of 36 hours before disinfectant rinsing.(g) Alternatively, a facility may use a 4 percent formaldehyde solution stored for at least 24 hours at room temperature should the facility require flexibility. All other requirements in subsections (d) and (e) shall be applicable.(h) For purposes of subsections (e), (f) and (g) room temperature shall mean a temperature thermostatically controlled between 22°C (72°F) and 30°C (86°F).Cal. Code Regs. Tit. 22, § 75206
1. New section filed 4-8-87; effective thirtieth day thereafter (Register 87, No. 16). Note: Authority cited: Sections 208(a), 417.10, 1225 and 1275, Health and Safety Code. Reference: Sections 417.10- 417.15, 1226 and 1276, Health and Safety Code and Section 15376, Government Code.
1. New section filed 4-8-87; effective thirtieth day thereafter (Register 87, No. 16).